Leaflet: information for the user

amlodipino cinfa 5 mg EFG tablets

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

amlodipino cinfa contains the active substance amlodipine which belongs to a group of medicines known as calcium antagonists.

amlodipino cinfaisusedto treathigh blood pressure(hypertension)ora certain typeofchest pain called angina, which includes a less common type known asPrinzmetal's anginaorvariant angina.

In patients with high blood pressure this medicine works by relaxing blood vessels, allowing blood to flow through them more easily. In patients with angina, amlodipino cinfa improves blood flow to the heart muscle, which receives more oxygen as a result and the chest pain is prevented. This medicine does not provide immediate relief from chest pain due to angina.

Do not take amlodipino cinfa

• If you are allergic to amlodipino, or to any of the other components of this medication (listed in section 6), or to any other calcium antagonist. This may cause itching, skin redness, or difficulty breathing.
• If you have very low blood pressure (hypotension).
• If you have a narrowing of the aortic valve (aortic stenosis) in your heart or cardiogenic shock (a condition in which the heart is unable to pump enough blood to the body).
• If you suffer from heart failure after a heart attack.

Warnings and precautions

Consult your doctor or pharmacist before starting to take amlodipino cinfa.

You must inform your doctor if you have or have had any of the following conditions.

• Recent heart attack
• Heart failure
• Severe increase in blood pressure (hypertensive crisis)
• Liver disease
• You are an elderly person and your dose needs to be increased

Children and adolescents

Amlodipino has not been studied in children under 6 years of age. Amlodipino should only be used to treat high blood pressure in children and adolescents from 6 to 17 years of age (see section 3).

For more information, consult your doctor.

Other medications and amlodipino cinfa

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Amlodipino may affect or be affected by other medications, such as:

• ketoconazol, itraconazol (antifungal medications)
• ritonavir, indinavir, nelfinavir (also called protease inhibitors used to treat AIDS)
• rifampicina, eritromicina, claritromicina (antibiotics)
• Hypericum perforatum(St. John's Wort)
• verapamilo, diltiazem (heart medications)
• dantroleno (infusion for severe body temperature abnormalities)
• tacrolimus, sirolimus, temsirolimus, and everolimus (medications used to modify the functioning of the immune system)
• simvastatina (cholesterol-lowering medication)
• ciclosporina (immunosuppressant)

If you are already taking other medications to treat high blood pressure, amlodipino may lower your blood pressure even further.

Taking amlodipino cinfa with food and drinks

People taking amlodipino should not consume grapefruit or grapefruit juice.This is because grapefruit and grapefruit juice may cause an increase in the blood levels of the active ingredient amlodipino, which may lead to an unpredictable increase in the effect of lowering blood pressure.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

The safety of amlodipino during pregnancy has not been established.

Breastfeeding

Amlodipino has been shown to pass into breast milk in small amounts.If you are breastfeeding, or are about to start, you must inform your doctor before taking amlodipino.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

Amlodipino may affect your ability to drive or operate machinery.If the tablets make you feel unwell, dizzy, or tired, or give you a headache, do not drive or use machinery and consult your doctor immediately.

amlodipino cinfa contains sodium.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended initial dose is 5 mg of amlodipine, once a day. The dose can be increased to 10 mg of amlodipine, once a day.

You can take this medication before or after meals. It should be taken at the same time every day, with a glass of water. Do not take amlodipine with grapefruit juice.

Use in children and adolescents

For children and adolescents (between 6-17 years of age), the recommended initial dose is usually 2.5 mg per day. The maximum recommended dose is 5 mg per day.

Currently, amlodipine 2.5 mg is not available and the 2.5 mg dose cannot be obtained with amlodipine cinfa 5 mg tablets since these tablets are not manufactured to be divided into equal parts.The groove is only for breaking the tablet if it is difficult to swallow it whole.

It is essential not to interrupt the administration of the tablets. Do not wait for the tablets to run out before consulting your doctor.

If you take more amlodipine cinfa than you should

The ingestion of too many tablets can cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, dazed, lightheaded, or weak.If the drop in blood pressure is severe, it can cause shock. You may feel your skin cold and wet and could lose consciousness.

Excess fluid can accumulate in the lungs (pulmonary edema) causing difficulty breathing that can develop up to 24-48 hours after ingestion.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take amlodipine cinfa

Do not worry. If you forgot to take a tablet, do not take that dose. Take the next dose at the correct time.Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with amlodipine cinfa

Your doctor will indicate for how long you should take this medication. Your disease may recur if you stop taking this medication before your doctor tells you to.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Go to your doctor immediately if you experience any of the following side effects after taking this medicine.

• Sudden hissing sounds when breathing (sudden sibilance), chest pain, shortness of breath, or difficulty breathing
• Swelling of the eyelids, face, or lips
• Swelling of the tongue and throat that causes severe difficulty breathing
• Severe skin reactions that include intense skin rash, blisters, skin redness all over the body, severe itching, blister formation, skin peeling, and skin inflammation, Stevens-Johnson syndrome, toxic epidermal necrolysis, or other allergic reactions
• Heart attack, abnormal heart rhythm
• Pancreatitis that can cause severe abdominal pain and back pain accompanied by a great sense of discomfort.

The following very common side effect has been reported. If this causes problems or lasts more than a week, consult your doctor.

Very common (may affect more than 1 in 10 patients)

• Edema (fluid retention)

The following frequent side effects have been reported. If any of these cause problems or last more than a week, consult your doctor.

Frequent (may affect up to 1 in 10 patients)

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (feeling the heartbeat), shortness of breath
• Abdominal pain, feeling of discomfort (nausea)
• Alteration of bowel habit, diarrhea, constipation, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling of the ankles

The following side effects have been reported or are included in the following list.If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Rare (may affect up to 1 in 1,000 patients)

• Confusion

Very rare (may affect up to 1 in 10,000 patients)

• Decreased white blood cell count, decreased platelet count that may cause easy bleeding or unusual bruising
• High blood sugar (hyperglycemia)
• A disorder of the nerves that may cause muscle weakness, numbness, or tingling
• Gingivitis
• Abdominal swelling (gastritis)
• Abnormal liver function, hepatitis, yellow skin discoloration (jaundice), increased liver enzymes that may affect some medical tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin eruptions
• Sensitivity to light
• Movements combining rigidity, tremor, and/or movement disorders

Frequency not known (cannot be estimated from available data)

• Tremor, stiff posture, mask-like face, slow movements, and a dragging and unsteady gait

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGREpointofyour pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of amlodipine cinfa

Appearance of amlodipine cinfa and contents of the packaging

amlodipine cinfaare white, non-coated, scored tablets on one face and engraved with “5” on the other. They are presented in PVC/Al blisters in packaging with 30 or 500 (clinical packaging) tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain.

Responsible(s) for manufacturing

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain.

or

Adamed Pharma, S.A.

ul. Marszalka J. Pilsudskiego 5

95-200 Pabianice

Poland

Date of the last review of this leaflet:July 2022

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS).

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/65460/P_65460.html

QR code to:https://cima.aemps.es/cima/dochtml/p/65460/P_65460.html